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Health Canada Medical devices

Titan® Inflatable Penile Prosthesis

Issued November 10, 2023
Issue
Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification. Recall Start Date: October 30, 2023
Hazard description
Performance
Product
Product name
Titan® Inflatable Penile Prosthesis
Reference
ID
RA-74577